Internal Issues

ISO 9001:2015, clause 4, Context of the Organization, includes requirements for the organization to determine its:

  • external and internal issues (4.1)
  • relevant interested parties (4.2)
  • quality management system scope (4.3)
  • processes and their interaction (4.4)

This article is focused on clause 4.1 and determining internal issues. A different article in this newsletter addresses external issues. Both articles include the same Requirements, Notes, and References sections. The Guidance sections are unique to internal issues or external issues.

4.1 Understanding the organization and its context


An organization must determine the external issues and internal issues that are relevant to its purpose and strategic direction, as well as, those that affect its ability to achieve the intended results of its quality management system.

The organization must monitor and review information about these external and internal issues.


1. Issues can include positive and negative factors or conditions for consideration.

2. An understanding of the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local.

3. An understanding of the internal context can be facilitated by considering issues related to values, culture, knowledge, and performance of the organization.


According to ISO 9001:2015, clause 9.3.2.b, changes to these issues are inputs to management review. These issues are also referenced in clause 4.3 as considerations for determining the scope of the quality management system. They are mentioned again in clause 6.1.1 as considerations for determining the risks and opportunities faced by the quality management system.


Examples of possible internal issues are:

  • Organizational structure
  • Expected retirement of key personnel
  • Availability of reliable, qualified workforce
  • Capacity for product production; service delivery
  • Addition of a second shift for increased sales
  • Aging machinery or obsolete equipment
  • Aging workforce and new hires
  • Formation of a labor union
  • Relocation of the company
  • Business performance
  • Rules for decision making
  • Lack of organization knowledge
  • Cost of quality
  • Poor customer satisfaction; complaints
  • Inefficient, ineffective processes
  • Resilience of infrastructure
  • Extent of outsourcing
  • Contractual arrangements with customers
  • Relationship with investors
  • Service level agreements with customers
  • Expiration of government funding
  • Work stoppage
  • Computer hacking
  • Environmental pollution
  • Social media coverage
  • Organizational culture and behavior
  • Corporate governance

A structure for identifying the distinct types of internal issues is the McKinsey 7S Model:

1. Strategy – Purpose of the business and the way the organization seeks to enhance its competitive advantage.

2. Structure – Division of activities; integration and coordination mechanisms.

3. Systems – Formal procedures for measurement, reward, and resource allocation.

4. Shared Values – Beliefs and principles which guide decisions and behavior of management and employees.

5. Skills – Core competencies and distinctive capabilities.

6. Staff – Human resources, demographic, educational, and attitudinal characteristics.

7. Style – Typical behavior patterns of key groups, such as managers and other professionals.

The 7S model is based on the theory that, for an organization to perform well, these seven elements need to be aligned and mutually reinforcing. The model can be used to understand how the organizational elements are interrelated and ensure that the wider impact of changes made in one area is taken into consideration.